Life Plans Intervention Study

HIV/AIDS Clinical Trial

Official title:

Life Plans of Young Adults in Rural KwaZulu-Natal: an Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215901
• Other study ID #: H-36591
• Secondary ID: 5K01MH105320
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: December 14, 2017

Study information

• Verified date: September 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The mass provision of HIV treatment in rural KwaZulu-Natal, South Africa has raised adult life expectancy by 18 years since 2003. We will conduct a population-based survey to assess young adults' beliefs about HIV, HIV treatment, and expectations for the future in the era of mass HIV treatment. Thh investigators will conduct a randomized evaluation to assess whether a short video providing young adults with information on longevity gains from HIV treatment affects young adults survival expectations, hope for the future, and health and educational behaviours, including uptake of HIV testing, the study's primary outcome.

Description:

The proposed study will investigate survival expectations and health behaviours among young adults ages 18 to 25. Potential respondents will be sampled at random from a population listing from the demographic and health surveillance system of the Africa Health Research Institute (AHRI) in Somkhele, South Africa. Potential participants will be visited at home to be recruited for the study.

1. Consent. The study will be described and participants will provide written informed consent to participate in the study, including the baseline visit, a follow-up survey, and permission to link with demographic surveillance data.

2. Baseline interview (1.5 hours)

2.a) Survey module. First, a survey questionnaire will be conducted with young adults ages 18 to 25 to learn about their survival expectations, perceptions of HIV risks and treatment, future-oriented behaviours such as smoking, alcohol use, HIV risk behaviors, savings, locus of control, mental health, time and risk preference, and life satisfaction.

2.b) Video intervention. After the survey module, study participants will be randomized into treatment and control groups. Both interview participants and interviewers will be blinded to treatment assignment prior to this stage. The treatment group will be shown a 10 minute video that provides information on the changes in HIV-related mortality and life expectancy in the Demographic Surveillance Area between 2003 and today (an increase of about 18 years in the average length of life). The video includes testimonials from community members who have lived long and fulfilling lives on HIV treatment. The goal of the video is to increase measured survival expectations, hope, locus of control, and future orientation. The control group will receive a 10-minute video clip on another topic. Participants will be asked briefly for an open-ended response to the video: "what did the video make you think about?" which will be transcribed or recorded.

Details on randomization procedures: treatment assignment will be determined at the level of the household, such that if there are multiple respondents per household, they receive the same treatment. Households will be randomized to the intervention video or control ex ante. Though treatment assignment will occur ex ante, it will only be revealed - to both the field workers and the respondents - after completing the initial survey module. Ex ante randomization has two benefits. First, as a quality control, ex ante randomization limits the opportunity for violations of treatment assignment. Second, it increases power by enabling stratification on baseline variables. Because the study is nested in the AHRI population surveillance, treated and control households can be balanced on household size, wealth, and other characteristics. Treated and controls will be randomized at a 1:1 ratio, with controls further sub-randomized 1:1 to attention-placebo vs. pure control.

2.c) Re-survey module. Immediately after the video intervention, all study participants will be asked a brief subset of the survey module questions to re-measure survival expectations, locus of control, and life satisfaction. This step will estimate the immediate impact of the video intervention on beliefs.

2.d) Uptake of investment behaviors. 2.d.i) HIV Testing Voucher. Immediately after the re-survey module, participants will be offered a voucher for free HIV testing at a local pharmacy. Redeemed voucher numbers will be collected from the pharmacy to assess uptake of testing. No test results will be collected. This information will be stated clearly on the voucher.

2.d.ii) Invitation to Job Search Skills Workshop. Participants will be invited to a job skills training workshop delivered in partnership with a local human resources consultant. The workshop will inform participants of the types of job opportunities that exist, what skills and qualifications employers are looking for, as well as what strategies can be used to increase chances of getting a job. (For example, recent research in South Africa finds that employers are 60% more likely to respond to job applicants that include a letter of reference.) The workshop will be held at a convenient location 1-3 weeks after the baseline interview and attendance of study participants will be recorded. R10 will be provided to attendees to assist with travel expenses. The goal is to measure differences in uptake across treated and control arms, which will provide short-run evidence of the impact of the video on human capital investment behaviours.

2.d.iii) Savings choice. Immediately after the giving participants the HIV testing voucher, all participants will be offered the opportunity to save a portion of their participation compensation (R100) using a labelled box with a key that we will provide them. We provide this choice for study participants so that we can immediately measure intentions for future-oriented behaviour and to estimate the video's short-term effect based on differences in savings chosen between the treatment and control group.

2.d.iv) Condom offer. Participants will be offered the opportunity to purchase discount condoms and the number purchased will be recorded.

3. Follow-up interview at 2 months. Study participants will be contacted 2 months after their initial interview and provided with a follow-up survey that measures survival expectations, locus of control, and life satisfaction, mental health, savings, health behaviours, and (if applicable) schooling status. Participants will receive R50 in compensation for participation in the follow-up survey.

4. Surveillance Follow-up. Data from this study will be linked at the individual level to the AHRI population surveillance, which contains data on HIV testing, schooling, and employment. Participants will be visited approximately six weeks after the baseline survey and offered HIV testing as part of the AHRI surveillance. Passive follow-up through the surveillance is anticipated in future years, although this is beyond the scope of the registered trial. Linkage will be conducted by AHRI staff with access to identifying information in the population surveillance. After the conclusion of data collection and linkage, the key linking identifying data collected in this study to survey responses will be destroyed and only the de-identified ID number used in the demographic surveillance will remain. Participant contact details (not linked to data) will be retained in order to disseminate findings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• resides in Africa Health Research Institute demographic surveillance area, specifically bounded structures to be visited during the last trimester of the surveillance in the "Southern PIPSA" area.

• member of a household in the AHRI demographic surveillance

• 18 to 25 years of age

Exclusion Criteria:

• <18, >25 years

• not a member of a household under surveillance

• not resident in the surveillance area

Related Conditions & MeSH terms

• Chronic HIV Infection
• Health Knowledge, Attitudes, Practice
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• A Beautiful Future Video
Video delivering information on the longevity gains due to HIV treatment in the area.
• Active Control Video
Video on another topic.

Locations

Country	Name	City	State
South Africa	Africa Health Research Institute	Somkhele	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Africa Health Research Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Participated in HIV Testing	Participants were provided a voucher at baseline for free HIV testing at a private pharmacy in the area. This voucher could be used at any time within four weeks after baseline. Participants were also visited by an AHRI demographic and health surveillance team approximately six weeks after baseline during which all household members were offered a home-based rapid HIV test. This outcome takes the value of 1 if the participant used the HIV testing voucher OR participated in HIV testing during the household surveillance visit, and zero if the participant did not use the HIV testing voucher AND did not participate in HIV testing during the household surveillance visit.	6 weeks
Secondary	Use of HIV Testing Voucher	Participants were provided with a voucher for free HIV testing at a local service provider; use of voucher was assessed by obtaining voucher numbers and redemption dates from the service provider.	4 weeks
Secondary	Participation in HIV Testing or Care Services	Same as primary outcome, but also including linkage to clinical HIV services (as assessed by the presence of a CD4 count)	3 months
Secondary	Attendance at Job Search Skills Workshop	At the end of the baseline interview, participants were invited to a job search skills workshop facilitated by a local human resources consultant. Workshops were held at locations convenient to the study area and occurred 1-2 weeks after the baseline survey. Attendance was taken at the workshop. This outcome variable takes the value 1 if the participant attended the workshop and the value 0 if the participant did not attend the workshop.	2 weeks
Secondary	Condoms Purchased	At the end of the baseline survey, participants were offered the opportunity to purchase discount condoms. Participants were given 20 Rand and the opportunity to buy up to 10 condoms for 2 Rand each. The number purchased (0 to 10) was recorded.	Immediate post-test
Secondary	Money Allocated to Savings Tin	At the end of the baseline survey, participants were offered the opportunity to allocate a portion of their participation incentive (R100) to a savings tin. The amount saved was recorded. 13.5 Rands = 1 US dollar at the time of study.	Immediate post-test
Secondary	Change in Subjective Life Expectancy (Baseline to Immediate Post-test)	Subjective life expectancy was calculated as the under the subjective survival curve. Respondents were asked about the chances of surviving to age 30, 40, ..., 80 years. We linearly interpolated the responses and calculated the area under this curve, which we defined as subjective life expectancy (number of years expected to live between current age and age 80). Subjective life expectancy was elicited at baseline (pre-intervention), baseline (post-intervention), and at 8 weeks. This outcome measure reflects the immediate change in reported survival expectations induced by the intervention.	Baseline pre-test, Immediate post-test
Secondary	Subjective Life Expectancy (2 Months)	Subjective life expectancy was calculated as the under the subjective survival curve. Respondents were asked about the chances of surviving to age 30, 40, ..., 80 years. We linearly interpolated the responses and calculated the area under this curve, which we defined as subjective life expectancy (number of years expected to live between current age and age 80). Subjective life expectancy was elicited at baseline (pre-intervention), baseline (post-intervention), and at 8 weeks. This outcome measure reflects the change in reported survival expectations at 8 weeks induced by the intervention.	8 weeks